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Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor (ILIAD)

Primary Purpose

Intracranial Aneurysm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D anatomical model of aneurysm
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intracranial Aneurysm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision Consent form signed The patient benefits from health insurance Exclusion Criteria: Legal incapacity Women at risk of pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    With 3D anatomical model

    Without 3D anatomical model

    Arm Description

    Surgery prepared using 3D anatomical model of the aneurysm

    Surgery prepared without 3D anatomical model of the aneurysm (routine care)

    Outcomes

    Primary Outcome Measures

    Proportion of patients with successful procedure
    Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor

    Secondary Outcome Measures

    Full Information

    First Posted
    December 16, 2022
    Last Updated
    September 26, 2023
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665309
    Brief Title
    Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
    Acronym
    ILIAD
    Official Title
    Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a preliminary randomised controlled trial comparing the use of pre-operative 3D models to select an intrasaccular flow disruptor for endovascular aneurysm cure.
    Detailed Description
    Patients will be randomised 3:1 either in the intervention or control group. Intervention consists of using the pre-operative Digital Subtraction Angiography (DSA) to create a 3D plastic model. This model is used to test different sizes of device. At the end of this pre-operative test a single device is recommended for the real procedure. The control group will use the current method for size selection (measurement of mean width and minimum height) on DSA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Aneurysm

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    With 3D anatomical model
    Arm Type
    Experimental
    Arm Description
    Surgery prepared using 3D anatomical model of the aneurysm
    Arm Title
    Without 3D anatomical model
    Arm Type
    No Intervention
    Arm Description
    Surgery prepared without 3D anatomical model of the aneurysm (routine care)
    Intervention Type
    Procedure
    Intervention Name(s)
    3D anatomical model of aneurysm
    Intervention Description
    Surgery prepared with 3D anatomical model of aneurysm
    Primary Outcome Measure Information:
    Title
    Proportion of patients with successful procedure
    Description
    Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor
    Time Frame
    Day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision Consent form signed The patient benefits from health insurance Exclusion Criteria: Legal incapacity Women at risk of pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guillaume CHARBONNIER, MD
    Phone
    +33381668502
    Email
    g1charbonnier@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guillaume CHARBONNIER, MD
    Organizational Affiliation
    CHU de Besançon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor

    We'll reach out to this number within 24 hrs